Infusomat Space P Instructions for Use

CONTENTS

CONTENTS Infusomat® Space P Overview ...3 Patient Safety

...5

Menu Structure / Overview ...8 Menu Structure / Navigation...9 Chapter 1

Operation ...11 1.1 Start of Infusion ...11 1.2 Entry With Different Combinations of Rate, VTBI (= Volume To Be Infused) and Time ...13 1.3 Bolus Application...14 1.4 Infusion Line Change and New Therapy Start ...15 1.5 End of Infusion ...15 1.6 Standby Mode...16

Chapter 2

Advanced Operations...17 2.1 Status Request of Pump when Infusion is Running...17 2.2 Rate, VTBI and Time Change Without Infusion Interruption and Reset of Status Menu Data ...17

Chapter 3

Special Functions* ...18 3.1 Dose Rate Calculation (Overview) ...18 3.2 Dose Rate Calculation (Operation) ...18 3.3 Drug Library...19 3.4 Patient Controlled Analgesia (PCA) ...20 3.5 Piggyback Function ...22

Chapter 4

Options...24 4.1 Occlusion Pressure...24 4.2 Data Lock...24 4.3 Bolus Rate...25 4.4 KVO-Mode...25 4.5 Contrast / Display Light / Keypad Light ...26 4.6 Alarm Volume...26 4.7 Date / Time ...26 4.8 Macro Mode ...26 4.9 Language ...26 4.10 Upstream Occlusion Pressure...27

Chapter 5

Alarms ...28 5.1 Device Alarms ...28 5.2 Pre-Alarms and Operating Alarms...28 5.3 Reminder Alarms...31 5.4 Alarm Hints...32

Chapter 6

Battery Operation and Maintenance ...33

Chapter 7

Start Up Graphs and Trumpet Curves...35

Chapter 8

Technical Data ...36

Chapter 9

Warranty / Training / TSC`** / Service / Cleaning / Disposal ...39

Chapter 10 Instructions for Use Accessory...41 Ordering

...46

*The availability of the listed features is depending on the configuration of the pump. **Technical Safety Check

2

INFUSOMAT SPACE® OVERVIEW

I N F U S O M AT ® S PA C E P O V E R V I E W Arrow up and -down Scroll through menus, change setting of numbers from 0-9, answer Yes/No questions. Arrow left and -right Select data from a scale and switch between digits when numbers are entered. Open a function while pump is running or stopped with the left arrow key.

q

Press to reset single values to zero and switch back to the previous screen/menu level.

Press to open the pump door.

c

x

Press to initiate bolus.

Yellow LED: Pre-alarm, reminder alarm Green / Red LED: Infusion occuring / device alarm, operating alarm Blue LED: Currently connected to SpaceControl

k

m

Open certain functions and press to confirm values/settings/alarms.

Press to link the pump to SpaceControl and to assign a barcode after scanning.

Press to turn pump on/off.

B o n

f S Press to Start/Stop infusion.

Cover of Battery Compartment Before changing the battery, always disconnect the pump from the patient and switch off the device. To remove the battery cover push the button below the battery compartment with a pointed pen and pull the cover away from device. Slide green locking mechanism on back of battery up and take out battery pack for exchange. A crank in order to open the pump door in case of emergency is attached to the inside of the battery compartment cover (for closer information see 1.4).

Port for drop sensor

Port P3 for future options

3

Port P2 for power supply, SpaceStation, connection lead (12V), combi lead and further accessory leads (staff call, service)

INFUSOMAT® SPACE P OVERVIEW

Pressure sensor

Opening lever

Safety clamp

Air sensor

Signal lamp

Line guide cover

Upstreamsensor

Fixaton of PoleClamp (Universal Clamp) Line up bar of pump with bar of PoleClamp and slide PoleClamp forward until locking mechanism clicks. To remove, press release button on frame, push handle down and pull PoleClamp bakkwards.

Transport A maximum of three pumps (Infusomat® Space P or Perfusor® Space) plus one SpaceControl may be stacked together. Avoid external mechanical influence. Locking Devices Together Line up the bar of the lower pump with the bar of the pump above and slide the lower pump backwards until the lock clicks and the green buttons are above each other. To disconnect, push green locking buttons of top pump device and slide bottom pump forward.

Pole Fixation Push the opening of the PoleClamp against the vertical pole and lock the screw tightly. Unscrew to release. For vertical fixation of PoleClamp push lever down and rotate either way until lever clicks into notch. Push lever for rotation. Caution: Do not lean on pump when attached to pole!

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PATIENT SAFETY

PAT I E N T S A F E T Y

w

Intended use

The Infusomat® Space Volumetric Infusion Pump System includes an external transportable electronic volumetric infusion pump, dedicated administration Read Instructions for Use prior to use. sets, and pump accessories. The system is intended for use on adults, pediatrics, The infusion device and neonates for the intermittent or continuous delivery of parenteral and enteral fluids through clinically accepted routes of administration. These routes should only be include, but are not limited to intravenous, irrigation/ablation, and enteral. The used by specially trained staff. system is used for the delivery of medications indicated for infusion therapy including but not limited to colloids and cristalloids, blood and blood components, Total Parenteral Nutrition (TPN), lipids, and enteral fluids. The Infusomat® Space Volumetric Infusion Pump System is intended to be used by trained healthcare professionals in healthcare facilities, home care, outpatient, and medical transport environments. Qualified medical staff should decide how the device should be used based on its features and specifications. For more details, please read the Instructions for Use. Operation • The initial training of the Infusomat® Space P is to be performed by B. Braun sales personnel or other authorized persons. After each software update, the user is required to inform himself about the changes to the device and accessories in the instructions for use. • Ensure the unit is properly positioned and secured. The pump must be positioned on a level surface if used in combination with the short stand. Do not position the pump above the patient. • Prior to administration, visibly inspect the pump for damage, missing parts or contamination and check audible and visible alarms during selftest. • Only connect to patient once the line has been correctly inserted and completely primed. Interrupt connection during line change to prevent incorrect dose delivery. • Select infusion line/catheter suitable for use with the intended medical application. • Position the infusion line free of kinks. • Recommended change of disposable each 24 h (or as per national hygiene regulations). • Installation in medically used rooms must comply with the appropriate regulations (e.g. VDE 0100, VDE 0107 or IEC-publications). Observe national specifications and deviations. • Do not operate the pump in the presence of flammable anaesthetics to prevent explosion. 5

PATIENT SAFETY

• Compare the displayed value with the entered value. Only start the infusion if the values showing are the same. • If staff call is used we recommend checking the equipment once after connecting the pump. • Protect the device and the power supply against moisture. • If the pump falls down or is exposed to force, it must be checked by the service department. • The displayed data must always be checked by the user prior to making further medical decisions. • During mobile use (homecare, patient transport inside and outside the hospital): Make sure the device is securely fixed and positioned. Positioning changes and severe shock can lead to minor changes in the delivery accuracy. • A supplemental patient monitoring must be carried out if life-saving medication is performed. • The air detector cannot detect air diffusing in the following components: three-way stopcocks, infusion adapters and further lines placed between pump and patient. • In case high potent drugs are given be sure to have a second infusion pump for that drug at hand. • Independant of the soft limits the selected values have to be the medically correct ones for the given patient. • In case values relevant for the dose rate calculation are changing always the flow rate will be updated and the dose rate will be fix. Enteral Nutrition The Infusomat Space may be used for entaral nutrition, too. Do not use enteral fluids for intravenous infusion as this may harm your patient. For this reason only use disposables dedicated and labelled for enteral nutrition. Transfusion The Infusomat Space may be uses for blood transfusion, too. For this therapy only use disposables dedicated and labelled for transfusion. Other components • Use only pressure-proof and compatible disposable items (min. 2 bar/ 1500 mm Hg) to avoid influencing performance data- which would result in impairing patient safety.

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• Where several infusion lines are connected on one single vascular access, the possibility of the lines exerting a mutual influence over each other cannot be excluded.

PATIENT SAFETY

• Refer to respective manufacturer’s information for possible incompatibilities of equipment with respect to drugs. • Use only compatible combinations of equipment, accessories, working parts and disposables with luer lock connectors. • Connected electrical equipment must comply with the relevant IEC/ENspecifications (e.g. IEC/EN 60950 for data-processing equipment). The user/operator is responsible for the system configuration if additional equipment is connected. The international standard IEC/EN 60601-1-1 has to be taken into account. Safety Standards Infusomat® Space P satisfies all safety standards for medical electrical devices in compliance with IEC/EN 60601-1 and IEC/EN 60601-2-24. • The EMC-limits (electro-magnetic compatibility) according to IEC/EN 60601-1-2 and IEC/EN 60601-2-24 are maintained. If the equipment is operated in the vicinity of other equipment which may cause high levels of interference (e.g. HF surgical equipment, nuclear spin tomography units, mobile telephones etc.) maintain the recommended protective distances from these devices. • The Infusomat® Space P fulfils the applicable requirements of EN 13718 to be used in the air, on the water and in difficult terrain. During transport the Infusomat® Space needs to be fixed on a suitable restraint system by means of SpaceStation or Pole Clamp SP. When stored under temperature conditions beyond the defined operating conditions the Infusomat® Space P needs to remain under room temperature at least one hour before usage. • As there is no dedicated norm existing for enteral feeding pumps the safety features of Infusomat Space P are also for enteral nutrition according to the a.m. norms. Safety Instructions • In case the demand button is used with SpaceStation the PCA pump has to be placed in the lowest slot of the lowest SpaceStation. • Access to the pump settings can be prohibited by DataLock 3. The code for DataLock level 3 should differ from the one for levels 1 and 2 in case the pump is only allowed to be used by pain management professionals. • When ending PCA and starting it again the therapy data are set to default values. • Using the demand button also the patient is a permitted user. With the demand button only a PCA-bolus can be requested. This is limited to predefined doses by drug list and pump settings.

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MENU STRUCTURE / OVERVIEW

MENU STRUCTURE / OVERVIEW Cutline o On/Off button x

C Clear button K OK button Q Keypad with arrow up, -down,

Door open button

s Start/Stop button f b Bolus button n

-left, -right button

m Connection button

Menu Structure Start Up Menu

Main Menu

Special Functions

Options Menu

Status Menu

Line selection

Change to PGY 1/2

Dose Rate Calculation

Occlusion Pressure

Total (Total volume)

Prime ?

Concentration

Drug Library

Data Lock

Total (Total amount)

Use last therapy ?

Weight

Piggyback

Bolus Rate

Total (Total time)

Use dose rate calculation ?

Dose

Change-over from continuous mode to PCA

KVOMode

Intermed. volume

Use drug library ?

Rate

Contrast

Intermed. amount

VTBI

VTBI

Display Light

Intermed. time

Time

Keypad Light

Line

Special Functions

Alarm Volume

Drug Info

Options

Date

PGY Change

Status

Time

Batt. cap.

Macro Mode

Version

Language

Upstream Pressure

In dose mode: Display of flow rate in large scale.

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The pump can be customized by (de-) activating the menu items of the Start Up (except VTBI) and Options Menu as well as the bolus function via the service program.

MENU STRUCTURE / NAVIGATION

MENU STRUCTURE / NAVIGATION Display

Meaning At the top of the screen the last therapy is indicated. Yes/No question can be answered by pressing u for yes or d for no.

Parameters which can be changed (e.g. rate in ml/h) are opened with l or k. When editing parameters, switch digits/levels using l r. White background indicates current digit/ level. Use u or d to change current setting. Help text on the bottom/top of the screen indicates options how to proceed (e.g. confirm rate with k, start infusion with s f or clear rate by pressing c). Typical display during infusion: Mains connection Battery status

Set pressure limit and current pressure Therapy profile Active VTBI- or time preselection Scrolling arrows indicate pump is infusing Set rate can be opened with l

Unit of drug application Total volume infused. Alternatively the intermediate volume can be displayed. Remaining time Remaining VTBI

All status information is available in the bottom line of the dislplay. The desired information can be selected by using d u and will be displayed permanently thereafter (e. g. drug long name, time until syringe empty etc.). n has been pressed while the pump is b infusing. Start manual bolus at 1200 ml/h by pressing k (see top of display) or proceed to set bolus limit with l (see bottom of display).

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MENU STRUCTURE / NAVIGATION

Display

Meaning This hint pops up if a user tries to edit or change a parameter by pressing l when that parameter is unable to be changed.

Set pressure level with l or r and confirm by pressing k. Cancel to edit pressure by using c.

Pre-alarms are indicated by a message on the display (e.g. “VTBI near end”), an audible tone and a flashing yellow LED. To confirm a pre-alarm press k.

In case of an operating alarm (e.g. "VTBI infused") the infusion stops, an audible tone sounds and the red LED flashes. Confirm alarm by using k. Confirming does not activate an acoustic feedback. Press and hold o for 3 sec to turn pump off. A white bar stretches from left to right and counts down the 3 sec. As long there is an infusion line inserted the pump will not turn off but will use standby.

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OPERATION Chapter 1

OPERATION 1.1 Start of Infusion • Ensure that the pump is properly installed. Check the equipment for completeness and damages. Do not attach the infusion bottle below the pump level. • Put the spike vertically into the infusion bottle. Fill the bottom part of the drop chamber by max. 2/3. • Fill the infusion line from bottom to top, then close the roller clamp. • If the device is connected to the mains, the display indicates the battery status, the mains connection symbol and the last therapy. • Press o to switch on the device. Observe the automatic self-test: The message “Self-test active” and the software version are displayed, two audible tones sound and all three LEDs (yellow, green/red and blue) flash once. Information about the power supply (mains or battery operation) and the set pressure level are indicated. In addition, the line type appears at first (provided that the line is already inserted). Then, the accumulated air volume and the max. size of air bubbles is indicated which is triggering the air alarm of the device. The pump offers the possibility to load up to four languages into the pump (depending on the number of the language specific characters), among which the user can choose during the operation of the pump. During the first ever start-up of the device, the user is requested to select the languages and to mark them with l. After that, the selection has to be confirmed by choosing the last menu item at the bottom of the list and pressing k. Then the desired language must be selected with t and confirmed with k. Answer the following question with d in order to activate the selected language. • Press c to start the direct entry of therapy parameters, or press x and u to open the pump door in order to continue with inserting the line. Caution: You may only insert the line while the device is switched on and the line guide element is inserted. Otherwise, there is the danger of freeflow. The pump is permitted to be used on a temperature scale from 18 - 35 °C. Do not use the pump beyond these temperatures. Never leave the pump unattended when inserting the tube. Caution: Inserting different lines into the pump is identical. Please see instructions and packaging of the different lines (standard, transfusion, opaque, enterel nutrition etc.) to receive information about preparation and usage of these lines.

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OPERATION Chapter 1 Insert the infusion line from right to the left. Make sure that the line is routed straight. At first, route the line through the upstream sensor. Then, insert the two-hole clip.

In the next step, attach the white clip without twisting the line.

Insert the freeflow clamp (see red arrow) in the opened aperture, in the direction indicated by the arrow, until the opening lever locks in and the safety clamp squeezes the lines (flashing signal lamp goes out).

• Close the pump door. Then select the inserted line with t and confirm it with l. Open the roller clamp. Caution: If a wrong line is selected the time until the pump goes into a pressure alarm may be prolonged. • Press u if the prime function is enabled to prime the infusion line with the rate displayed. Cancel priming with k. Repeat the procedure until the line is completely primed. Then press d to proceed. Note: During priming, all air and drop alarms are switched off. • Establish the patient connection. • Answer the question whether the old therapy is to be used either with u or d (the question can be deactivated via the service manual). If you select u, the pump jumps to the Main Menu. If you select d with no drop sensor connected, you must first enter a VTBI which is smaller than the container filling and confirm it with k. 12

OPERATION Chapter 1 Note: At rates smaller 1 ml/h the detection of a closed roller clamp cannot always be ensured due to physical reasons. Therefore it is recommended especially at small rates to use a drop sensor. Adjusting the delivey rate: • In the Main Menu, open the rate with l and set it with q. • Press s f to start the infusion. Running arrows on the display and the green LED indicate that the pump is infusing. Note: The running infusion can be cancelled at any time by pressing s f. The pump can be turned off at any time by pressing o for 3 sec (Exception: Data lock level 2) and as long a disposable is inserted.

1.2 Entry With Different Combinations of Rate, VTBI (= Volume To Be Infused) and Time The Infusomat® Space P offers the possibility to enter a volume- and time limit in addition to an infusion rate. When two of these parameters are entered, the third is calculated by the pump. If a volume and/or time is preselected, an arrow symbol is placed in front of one of these parameters in the Main Menu. It is called the “target”. During the infusion of the pump, this target symbol is displayed next to the moving arrows in the run display. This indicates that the pump has been programmed, either with a volume- or time limit. The assignment of the target symbol, apparent in the Main Menu, shows the established parameter for the application (VTBI or time). When the rate is changed, the so-called target parameter is principally not adjusted to the new rate but to the parameter which does not have the target symbol in front. After the infusion has started, the remaining VTBI and time are displayed in the Main Menu and the run display (values are counting down). 1.) Enter VTBI and time: The infusion rate will be calculated and displayed on the bottom of the display. Target: Volume • Select VTBI with t and open with l. • Enter VTBI with q and confirm with k. • Select time with t and open with l. • Enter time with q and confirm with k. Check calculated rate on plausibility. Proceed in the same way to calculate 2.) and 3.). 2.) Infusion with volume limit Enter rate and VTBI: The infusion time will be calculated and displayed on the bottom of the display. Target: VTBI 13

OPERATION Chapter 1 3.) Infusion with time limit Enter rate and time: The infusion volume will be calculated and displayed on the bottom of the display. Target: Time Changing already entered values of VTBI and time (rate, VTBI and time already exist at the point of change): a) Target symbol is placed in front of VTBI: • Change of VTBI => Adjustment of time. Old and new target: VTBI • Change of time => Adjustment of rate. Old and new target: VTBI b) Target symbol is placed in front of time: • Change of time => Adjustment of VTBI. Old and new target: Time • Change of VTBI => Adjustment of time. New target: VTBI

1.3 Bolus Application There are three ways to administer a bolus: 1.) Manual Bolus: Press n b. Then press k and hold button. Fluid is administered for as long as the button is held down. The infused bolus volume is displayed. The max. bolus time is limited to 10 sec. 2.) Bolus with volume preselection: Press n b. Then press l and set bolus dose limit by using q. Press n b to confirm and start bolus. Depending on the service tool settings an acoustic signal will sound after finishing the bolus volume. 3.) Bolus with rate calculation: Press n b. Then press l and set bolus dose by using q. Press k to confirm bolus dose. Set time with q in which a bolus is to be delivered. Calculated bolus rate is shown on top of the display. Press n b to confirm and start bolus. The unit of the bolus always depends on the selected dose. If the dose is for example selected as mg/kg/h, then the bolus will be given in mg/kg. If a dose is administered without a relation to the patient's weight (mg/h), then the bolus will be given in mg. You can use the service program to enter a default and a maximum bolus rate. Once a new therapy is started the device always returns to the default rate - even if the bolus rate was manually changed beforehand.. Note: If the bolus limit is not entered after pressing b n, the pump switches back into the run display automatically. Note: The infused volume during bolus with volume preselection counts up. In order to purge the line at any time while the pump is stopped press n b. Answer the following question by pressing u in order to start the purge process. Cancel by pressing k or any other key. 14

OPERATION Chapter 1 Caution: Take care not to overdose! Given a bolus rate of 1200 ml/h, 1 ml will be administered in just 3 sec. To cancel bolus infusion at any time press k. At low bolus volumes, under dosages due to the start up characteristic of the pump and the tolerances in the infusion system cannot be excluded. Disconnect patient while purging.

1.4 Infusion Line Change and New Therapy Start Note: Always interrupt the patient connection before changing a line to avoid dosing errors. Never let the pump run unattended when changing the line. Check and clean the safety clamp regularly. • Press s f to stop the delivery. The green LED goes out. Close the roller clamp and interrupt the patient connection. • Press x and open the pump door with u. Press down the green opening lever completely until it locks in place, remove the line and insert a new line. Note: If for an unknown reason the pump door cannot be opened anymore, you need to take a crank from the inside of the battery compartment cover. Use this crank to remove the emergency aperture cover of the pump. Place the crank in the aperture and turn it clockwise until the pump door opens. • Close the pump door, confirm the inserted line with k and open the roller clamp. • If required, prime the pump with u. Then press d to proceed. • Establish the patient connection and check the parameters with t. • Start the infusion by pressing s f. Note: A new therapy can be started at any time during a stopped infusion. If the pump is in the Main, Status or Options Menu, press C (repeatedly) and follow the instructions as described.

1.5 End of Infusion • Press s f to stop the infusion. The green LED goes out. Close the roller clamp and interrupt the patient connection. • Press x. Answer the question whether the pump door is to be opened with u. • Press down the green opening lever completely until it locks in place. Remove the line and close the pump door. • Press o for 3 sec to switch off the pump. Note: The settings will be permanently saved by the switched off device.

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ADVANCED OPERATIONS Chapter 1

1.6 Standby Mode In the case of extended interruption, the user has the option to maintain the set values. • Press s f to stop the infusion. Then press o for less than 3 sec. • Confirm that the device is supposed to switch to stand-by by pressing u. • The default time for standby is displayed. Accept the default time with k or change it with q (0-24 hours) and then confirm it by pressing k. => While the pump is in the standby mode, it’s display shows the drug and the remaining time for this mode. Change of remaining time by pressing k. Exit standby by pressing c .

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ADVANCED OPERATIONS Chapter 2

ADVANCED OPERATIONS 2.1 Status Request of Pump when Infusion is Running Press c to switch between run display and Main Menu while the device is infusing. Navigate through the menu using t to check parameters. In order to check the menu parameters in the Status-/Options Menu, select "Status" respectively "Options" in the Main Menu, open menu with l and scroll through menu with t.

2.2 Rate, VTBI and Time Change Without Infusion Interruption and Reset Of Status Menu Data • Press c when the pump is in the run display in order to switch to the Main Menu. Select rate/VTBI/time with t and press l in order to open the parameter. • Enter new value with q and confirm with k. Reset Status Menu Data: The parameters intermediate volume and -time can be reset when the pump is infusing or when the pump has stopped. • Select “Status” in Main Menu with t and press l. • Highlight intermediate volume (in ml) or intermediate time (in h:min) with t and open parameter with l. • Reset values by pressing u. Both parameter total volume and -time, are displayed in the pump as "Total" with the according unit and can be reset by starting a new therapy. A second way to reset the parameters when the pump is in the Main Menu: Press c, answer question whether the last therapy is to be used with u and reset the values with u. The type of the inserted line is displayed in menu item „Line“ and cannot be changed once it has been confirmed at the beginning of the infusion. The drug info states the drug name, the name of the drug list and its date of origin. If the change from the secondary to the primary infusion will be performed manually or automatically will be displayed in line “PGY change”. The current battery capacity in hours and minutes is displayed in the menu item “Battery Cap.” and the current software version in menu item "Version".

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SPECIAL FUNCTIONS Chapter 3

SPECIAL FUNCTIONS 3.1 Dose Rate Calculation (Overview) The dose rate calculation enables a calculation of the rate in ml/h from the entered dose parameters. Infusion rate [ml/h] =

Dose x Patient weight (optional) Concentration

[

]

Setting parameters: 1. Concentration as the amount of the active ingredient per volume. - Amount of the active ingredient in µg, mg, mmol, IU or mEq. - Volume in ml. 2. Where necessary: Patient weight in kg or lbs. 3. Dose prescription: - time related as the amount of the active ingredient per min, h or 24h. - time and patient weight related as the amount of the active ingredient per kg per min, h or 24h. 4. Where necessary: VTBI in ml.

3.2 Dose Rate Calculation (Operation) a Select dose rate calculation with l. a Select the unit of the active ingredient with T and confirm it with l. a Enter the concentration by entering the amount of the active ingredient and the volume. In order to do so set the values with q and confirm with k. a If the patient's weight does not need to be entered press d. Press u for a time and weight related calculation, set the patient weight with q and confirm it with k. a Select the dose prescription with t and confirm it with l. a Set the dose with q and confirm with k. The rate will be automatically calculated and displayed at the bottom of the display. a Check the calculated rate and if necessary the adapted parameters with t on plausibility before starting the infusion with s f. a Check the parameters with t on plausibility before starting with s f. Concentration and dose can belatedly be changed in the Main Menu in the same way as the rate, VTBI and time (compare 2.2). The effect of dose modifications on other parameters is shown at the bottom of the display. Additionally the total and intermediate amount of the infused drug can be 18

SPECIAL FUNCTIONS Chapter 3 taken from the Status Menu. These can be checked and reset in the same way as the other total and intermediate values. A deactivation of the dose rate calculation is only possible when the pump is stopped. Press c from Main Menu and then press d.

3.3 Drug Library Up to 720 drug names including therapy data and information can be stored in 15 categories. The loading process into the pump can be performed using a separate PC program („Drug List Editor Space“). Note: The drug library can be started over the Start Up and Special Functions Menu. The user has to make sure prior to the therapy start that the drug library in the pump complies with the patient target group. The name of the drug library (see headline) will be displayed on the pump. There are different ways of activating the drug library. This can be done while the infusion is running or when the pump is stopped. On the one hand, a drug name including the according therapy data can be taken from the drug library. On the other hand, if a rate, VTBI and/or time were already defined in the Main Menu, the drug name and the adjusted values of the data set will be loaded.If a dose rate calculation has already been started a belated assignment of the drug name nevertheless is possible. In the following the loading of a drug including the according parameters will be described: •

Open the drug library by pressing l.

•

Navigate through list with t and select the drug from category in alphabetical order (all drugs) or within a category with l.

•

Confirm the displayed drug information with l.

•

Check if the drug short name in the Main Menu is the same as the selected drug. Check the parameter in the Main Menu with t and start infusion with s f.

Hard Limits: If the set rate/dose/bolus volume and bolus rate exceed the values stored in the drug library (hard limits), the drug will be rejected, a hint will be displayed and the pump will fall back into the drug selection. If this occurs while the pump is infusing the pump will continue to administrate. Soft Limits: For the same parameters so called soft limits can be preset via the Drug List Editor. These can be exceeded without any constraint. The following symbols 19

SPECIAL FUNCTIONS Chapter 3 that describe the status with regard to the soft limits are being displayed: The infusion is within the range of the minimum and maximum soft limits

=

The infusion is within the range of the maximum soft limit

=

The infusion is within the range of the minimum soft limit

=

Violation of the upper soft limit

=

Violation of the lower soft limit

=

No soft limit is defined

=

Only a drug name is available (It is possible to select a drug name only from the drug library)

=

The limits of the drug library have to comply with the limits of the pump and the disposable. Note: An adequate monitoring when infusing highly potent drugs is recommended. Note: In case a drug from the drug library is selected and the pump is running under dose rate calculation the initial values will be overwritten by the drug library values if selected.

3.4 Patient Controlled Analgesia (PCA) For PCA a drug list with at least one drug activating the profile PCA is necessary. By this the conditions for an effective and safe therapy are defined. Switch on pump with o and wait until self-check is finished. Depending on the settings the choice of a drug is offered direcly or the pump is in “Main Menu”. Select “Special Functions” with t from “Main Menu” and confirm with l. After the selection the pump offers additional drug related Information which are confirmed by l. Select profile PCA by using and confirm with t .The therapy settings stored in the drug list are displayed *.

*Bolus volume is the volume of a single bolus the patient may demand. Max. Limit is the amount of drug or volume a patient may demand within a certain time in total. Lockout is the time in between two boli.

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